The first drug to prevent HIV infection was supported by a federal advisory panel in the U.S., paving the way for approval, marking a milestone in the struggle of 30 years against the virus that causes AIDS.
In a series of votes, an advisory panel of the Food and Drug Administration (FDA for short) recommended approval of Truvada pill daily for healthy people who are at high risk of contracting HIV, including gay and bisexual men and heterosexual couples in which one partner is HIV positive.
Gilead Sciences Inc., based in Foster City, California, has been marketed since 2004 as Truvada treatment for people who are infected with the virus. The drug is a combination of two older drugs against HIV, Emtriva and Viread. Doctors usually prescribe it as part of a cocktail of drugs to suppress the virus.
While the panelists at the end supported Truvada for prevention, 12-hour meeting revealed a number of concerns generated by the first drug to prevent HIV.
In particular, the panel discussed whether Truvada can lead to reduced condom use, the surest defense against HIV. The experts also questioned the efficacy of the drug in women who have shown much lower rates of protection in the studies.
Panelists struggled to pinpoint steps to ensure that patients take the pill every day. In clinical trials, patients who did not take her medication diligently remained unprotected, and is even more likely that patients forget to take it.